The National Institutes of Health reports that each year 2,000,000 Americans develop deep venous thrombosis (DVT). Of these, about 600,000 are hospitalized for pulmonary embolism (PE) and 60,000 are fatal. Degenerative muscle fiber condition and diminishing muscle contraction performance are factors associated with aging, diabetes, obesity, inactivity, and life style factors including unhealthy nutrition. Left untreated, these factors could result in peripheral blood pooling and the development of PE or DVT. Peripheral blood pooling and associated diminished blood circulation has other consequences such as inadequate delivery of nutrition and oxygen to parts of the body including the brain, and that could result in mild cognitive impairment with progression to Alzheimer's disease. A method to counter these negative factors to human health irrespective of individual mobility status and without side effects is not available.
Medication to prevent blood clot include blood thinners (anticoagulants) such as heparin and warfarin (Coumadin); aspirin as oral and liquid antiplatelet agents; low-molecular-weight heparin Dalteparin (FRAGMIN®), Enoxaparin (LOVENOX®) and Tinzaparin (INNOHEP®) heparin sodium unfractionated heparin; Factor Xa inhibitors Fondaparinux (Arixtra®) Rivaroxaban (XARELTO®); and Vitamin K antagonists. While the thinning action prevents coagulation and thereby prevents blood clots, there is great potential that increased bleeding following surgery, excessive bleeding from injuries, and internal bleeding could occur.
Devices to prevent blood clots include compression stockings to reduce swelling by compressing the leg and keeping blood flowing; intermittent pneumatic compression device to inflate and deflate with air pump to squeeze the leg; and venous foot pump to inflate and deflate with air pump to increase blood flow in the leg. However, mechanical compression therapy exemplified by U.S. Pat. No. 6,123,681 does not improve the decline in the physiologic system such as fading motor unit activation and muscle fiber excitability. Effectiveness may depend on the level and state of individual adipose tissue even when transportability of the device is guaranteed. None of these mechanical devices are as effective as the pharmaceutical drugs described above, and the devices may be noisy and patients are prevented from ambulation during use. These contradictions draw consistent complaints from patients leading to lack of compliance and inability to overcome the intended problem described above. Electrical stimulation devices have found use in prevention of DVT. The device disclosed in U.S. Pat. No. 6,226,552 “Neuromuscular electrical stimulation (NES) in prevention of deep vein thrombosis,” is intended to conduct electrical current to a patient's limb, contracting the superficial muscles. In U.S. Pat. Nos. 6,181,965; 6,175,764; and 6,051,017, implantable micro-stimulators are disclosed. While NES systems use less electrical current intensity and are thus more tolerable than painful functional electrical stimulation (FES) models, the NES method is invasive and requires surgery for implanting NES thin-film electrodes. Prolonged use of implanted thin film electrodes could suffer fatigue problems from mechanical stress as surrounding muscles strengthen, and thermal stress could occur when electric charges are not fully conducted away before the next inflow of current thereby creating local heating that may continue to build up along the electrode thin films. When the combined mechanical and thermal stress overcome the thin-film strength of materials, the thin films will breakdown and enter the individual's blood stream.
Physical exercise by the actions of contracting muscles during therapy has been proven to prevent blood clots. However, bed-ridden patients recovering from major surgery and others unable to exercise such as older adults do not take advantage of exercise to prevent blood clots. Therapy such as raising the leg while immobilized have been used, but this will not improve decline in muscle fiber excitability and motor activation due to age and immobility. People unable to exercise due to age or immobilization will be susceptible to blood clots and diminished health.
A whole body vibration (WBV) device was developed to provide exercise to the muscular and skeletal system. Current WBV device philosophy is to cause the displacement of the platform for human support to execute oscillatory vertical movements, or center pivoted platform triangular movements, or triplanar sonic movements. Some have been implemented for use while standing, seated or in bed, and the user has the option to select preferred platform motion frequency and displacement amplitude before use. U.S. Pat. No. 5,070,555 discloses a bed with footboard oscillation, with the footboard adaptable to be attached to either or both sides of a bed; U.S. Pat. No. 7,530,960 discloses a vibration platform having an upper surface and a bottom surface where a reversible motor is mounted and connected to a mounted drive shaft on the bottom surface. Platform motion occurs from unbalanced weight of a rotatable weight eccentrically mounted to the drive shaft in relation to another fixed weight also mounted to the drive shaft. In U.S. Patent No. 2004/0210173 by Swidle, a synchronous impact table with a support system has a control system, a power system coupled to the control system; a lift system coupled to the power system and the support system; and a patient support system coupled to the lift system. However, major drawbacks with applying current WBV devices to overcome problems described above are multi-faceted. There could be bone fracture by increasing the displacement level in order to obtain better outcome, and current WBV devices presents options to users to vary this operating parameter. Muscle fibers have different frequencies. Selected operating frequency may favor the muscle fiber type with twitch frequency close to the selection against other muscle fiber types which is unlike scenario during exercise and may cause tingling sensation. Selection of key therapy parameters at different locations renders standardization impossible.
The problem addressed by the embodiments of the present invention is to provide solutions to the problems described above without contraindications in existing solution methods as described above. The focus is to provide the physiologic system the ability to overcome problems described above safely. Individuals suffering from decline of muscle fiber excitation and motor unit activation due to age, prolonged immobilization following orthopedic and vascular surgery, disease and obesity face the problem of blood pooling that could progress to life threatening deep venous thrombosis, lack of adequate blood circulation, insufficient nutrient and oxygen to vital parts of the body including the brain. Given that no previously known device and method is effective without contraindications, or applicable irrespective of individual mobility status and ability to engage in physical therapy, there is a need for effective therapy device and method in preventing decline in muscle fiber excitation and motor unit activation, to deliver improved muscle contraction, blood flow and bone mineral density.